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Drug side effects

ibandronate Side Effects

The reactions most often reported to the FDA for ibandronate (also sold as Boniva), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

2,935
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2004 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of ibandronate come from 2,935 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 2,935 reports to the FDA Adverse Event Reporting System (FAERS) for ibandronate (Boniva): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

2,935

Reports Mentioning Death

274

9.3% of reports — not proof the medicine caused the death

Hospitalizations

655

22.3% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

ARTHRALGIA
243
DIARRHOEA
230
NAUSEA
219
FEMUR FRACTURE
216
HEADACHE
198
FATIGUE
190
FALL
165
DIZZINESS
163
PAIN
161
ASTHENIA
154
MYALGIA
140
PAIN IN EXTREMITY
139
VOMITING
138
BACK PAIN
132
DYSPNOEA
132
OSTEONECROSIS OF JAW
126
DEATH
125
INSOMNIA
122
ABDOMINAL PAIN UPPER
119

Who Reports Side Effects

Gender Distribution

Female 2,324 (89%)
Male 285 (11%)
Unknown 6

Age Distribution

0-17 11 (1%)
18-44 41 (3%)
45-64 498 (33%)
65-74 525 (35%)
75+ 412 (28%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 274 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 125
DIARRHOEA 70
FALL 68
ASCITES 66
AMAUROSIS FUGAX 63
CARDIO-RESPIRATORY ARREST 63
DYSPNOEA 63
EYE PAIN 63
ALTERED STATE OF CONSCIOUSNESS 62
BLINDNESS 62
COMA 62
HAEMORRHAGIC STROKE 62
SEPSIS 62
ARTHRALGIA 61
HEAD DISCOMFORT 61
PRURITUS 61
DIZZINESS 60
ASTHENIA 59
CHILLS 59
COUGH 59

Reactions in Hospitalization Reports

Top reactions in 655 reports where hospitalization was an outcome.

Reaction Reports
FEMUR FRACTURE 81
FALL 61
VOMITING 42
PYREXIA 41
DIARRHOEA 40
PNEUMONIA 38
NAUSEA 34
URINARY TRACT INFECTION 34
ASTHENIA 33
ANAEMIA 30
ARTHRALGIA 30
PAIN IN EXTREMITY 30
HYPERTENSION 29
PAIN 28
DIZZINESS 27
LOW TURNOVER OSTEOPATHY 27
STRESS FRACTURE 27
NEUTROPENIA 26

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What the FAERS Data Reveals About ibandronate Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 2,935 voluntary reports linked to ibandronate and its brand equivalents (Boniva), spanning 2004 through 2025. Of those, 274 (9.3%) listed death as an outcome and 655 (22.3%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 89% were female and 11% male; age distribution skews toward 65-74, with 525 reports in that bracket. The single most reported reaction is arthralgia with 243 submissions, followed by diarrhoea and nausea.

How to read these numbers

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.

Drugs With a Similar FAERS Report Volume

Other medications with a total FDA adverse-event report count closest to ibandronate's 2,935.